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ANDA Approvals
New Drug Applications and 505(b)(2) Applications
Third Quarter

This ANDA Approvals chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA.
Approval Date | Reference Listed Drug | Generic Drug Name | ANDA Holder | ANDA Applicant |
---|---|---|---|---|
07/03/2023 | Trileptal | Oxcarbazepine | Novartis | Zydus |
07/03/2023 | Pylera | Bismuth Subcitrate Potassium / Metronidazole / Tetracycline HCl | AbbVie | Riconpharma |
07/05/2023 | Jevtana Kit | Cabazitaxel | Sanofi | Mylan |
07/05/2023 | Immodium A-D | Loperamide HCl | Johnson & Johnson | Jubilant Cadista |
07/06/2023 | Vivitrol | Naltrexone | Alkermes | Teva |
07/06/2023 | Antizol | Fomepizole | Par | Gland Pharma |
07/07/2023 | Viibryd | Vilazodone HCl | AbbVie | Apotex |
07/07/2023 | Hexadrol | Dexamethasone Sodium Phosphate | Aspen Global | Geneyork Pharms |
07/07/2023 | Nicardipine Hydrochloride | Nicardipine HCl | Hikma | Micro Labs |
07/07/2023 | Pepsid | Famotidine | Salix | Carnegie |
07/10/2023 | Rozerem | Ramelteon | Takeda | Aurobindo |
07/10/2023 | Advil Dual Action with Acetaminophen | Acetaminophen / Ibuprofen | Glaxo | Marksans Pharma |
07/10/2023 | Leucovorin Calcium | Leucovorin Calcium | Hospira | Hainan Poly |
07/11/2023 | Benicar | Olmesartan Medoxomil | Cosette | Amneal |
07/11/2023 | Renagel | Sevelamer HCl | Genzyme | Aurobindo |
07/11/2023 | Macrobid | Nitrofurantoin (Monohydrate / Macrocrystals) | Almatica | Mankind |
07/11/2023 | Sterile water for Injection | Sterile water for Injection | Hospira | Nexus |
07/11/2023 | Xylocaine | Lidocaine HCl | Fresenius Kabi | Mankind |
07/11/2023 | Sodium Chloride | Sodium Chloride 23.4% | Abraxis | Fresenius Kabi |
07/12/2023 | Lyrica | Pregabalin | Upjohn | Cadila Pharms |
07/12/2023 | Potassium Chloride | Potassium Chloride | Pharma Res Software | Novitium Pharma |
07/12/2023 | Nexium 24 hour | Esomeprazole Magnesium | AstraZeneca | Aurobindo |
07/12/2023 | MetroGel-Vaginal | Metronidazole | Bausch | Cosette |
07/13/2023 | Chlorpromazine HCl | Chlorpromazine HCl | Upsher-Smith | Lupin |
07/13/2023 | Oxtellar XR | Oxcarbazepine | Supernus | Apotex |
07/13/2023 | Advil Dual Action with Acetaminophen | Acetaminophen / Ibuprofen | Glaxo | Granules |
07/13/2023 | Steglatro | Ertugliflozin | Pfizer / Merck | Aurobindo |
07/14/2023 | Otezla | Apremilast | Amgen | Dr Reddys Labs |
07/14/2023 | Iclusig | Ponatinib HCl | Takeda | Apotex |
07/14/2023 | Zebeta | Bisoprolol Fumarate | Teva | Prinston |
07/14/2023 | Sodium Phenylacetate / Sodium Benzoate | Sodium Phenylacetate / Sodium Benzoate | Maia Pharms | Navinta |
07/17/2023 | Cytoxan | Cyclophosphamide | Baxter Healthcare | Sagent Pharms |
07/17/2023 | Cortef | Hydrocortisone | Pharmacia and Upjohn | Aurobindo |
07/17/2023 | Cardine | Nicardipine HCl | Chiesi | Senores Pharms |
07/18/2023 | Chlorpromazine HCl | Chlorpromazine HCl | Upsher-Smith Labs | Alembic |
07/19/2023 | Otezla | Apremilast | Amgen | Aurobindo |
07/19/2023 | Leucovorin Calcium | Leucovorin Calcium | Hospira | Kindos |
07/19/2023 | Neurontin | Gabapentin | Viatris | Rising |
07/24/2023 | Mozobil | Plerixafor | Genzyme | Dr Reddys Labs |
07/24/2023 | Mozobil | Plerixafor | Genzyme | Teva |
07/24/2023 | Mozobil | Plerixafor | Genzyme | MSN |
07/24/2023 | Bumex | Bumetanide | Validus Pharms | Taro |
07/24/2023 | Mozobil | Plerixafor | Genzyme | Eugia Pharma |
07/24/2023 | Aggrastat | Tirofiban HCl | Medicure | Nexus |
07/24/2023 | Mozobil | Plerixafor | Genzyme | Amneal |
07/24/2023 | Mozobil | Plerixafor | Genzyme | Kindos |
07/25/2023 | Ranexa | Ranolazine | Gilead | Piramal |
07/25/2023 | Hemabate | Carboprost Tromethamine | Pfizer | Steriscience |
07/25/2023 | Chantrix | Varenicline Tartrate | PF Prism | Medley Pharms |
07/26/2023 | Mozobil | Plerixafor | Genzyme | Zydus |
07/26/2023 | Otezla | Apremilast | Amgen | Annora |
07/27/2023 | Inomax | Ulspira - Nitric Oxide | Mallinckrodt | Airgas Therapeutics |
07/27/2023 | Zithromax | Azithromycin | Pfizer | Hainan Poly |
07/27/2023 | Tobi | Tobramycin | Mylan | Micro Labs |
07/28/2023 | Rocaltrol | Calcitriol | Validus Pharms | Patrin |
07/28/2023 | Claritin | Loratadine | Bayer | Hetero Lab |
07/28/2023 | Azopt | Brinzolamide | Novartis | Padagis |
07/28/2023 | Mephyton | Phytonadione | Bausch Health | Sciegen Pharms Inc |
07/28/2023 | Dexamethasone Sodium Phosphate | Dexamethasone Sodium Phosphate | Fresenius Kabi | Gene York Pharms |
07/31/2023 | LO/Ovral-28 | Turqoz | Wyeth | Lupin |
07/31/2023 | Onglyza | Saxagliptin HCl | AstraZeneca | Amneal |
07/31/2023 | Onglyza | Saxagliptin HCl | AstraZeneca | Aurobindo |
07/31/2023 | Onglyza | Saxagliptin HCl | AstraZeneca | Mylan |
07/31/2023 | Kombiglyze ER | Saxagliptin / Metformin HCl | AstraZeneca | Mylan |
07/31/2023 | Onglyza | Saxagliptin HCl | AstraZeneca | Glenmark |
07/31/2023 | Onglyza | Saxagliptin HCl | AstraZeneca | Sun |
07/31/2023 | Kombiglyze ER | Saxagliptin / Metformin HCl | AstraZeneca | Sun |
07/31/2023 | Derma Smooth/FS | Fluocinolone Acetonide | Hill Dermac | Novel Labs |
07/31/2023 | Argatroban | Argatroban | Hikma | Gland Pharma |
08/01/2023 | Permethrin | Permethrin | Aurobindo | Dr Reddys Labs |
08/01/2023 | Dexamethasone Sodium Phosphate | Dexamethasone Sodium Phosphate | Fresenius Kabi | Hikma |
08/01/2023 | Chantix | Varenicline Tartrate | PF Prism | Mankind Pharma |
08/01/2023 | Alphagan P | Brimonidine Tartrate | AbbVie | Alembic |
08/01/2023 | Advil Dual Action with Acetaminophen | Acetaminophen / Ibuprofen | Glaxo | Bionpharma |
08/01/2023 | Mucinex DM | Guaifenesin / Dextromethorphan Hydrobromide | Reckitt Benckiser | Dr Reddys Labs |
08/02/2023 | Indocin | Indomethacin | Zyla Life Sciences | Zydus |
08/03/2023 | Aptiom | Eslicarbazepine Acetate | Sumitomo Pharma | Hetero Labs |
08/03/2023 | Revlimid | Lenalidomide | Celgene | Torrent |
08/03/2023 | Zyloprim | Allopurinol | Casper Pharma | Hetero Lab |
08/04/2023 | Xiidra | Lifitegrast | Novartis | Micro Labs |
08/04/2023 | Diclegis | Doxylamine Succinate / Pyridoxine HCl | Duchesnay | Bionpharma |
08/04/2023 | Vancomycin HCl | Vancomycin HCl | Mylan | Eugia Pharma |
08/04/2023 | Bentyl | Dicyclomine HCl | Allergan | Bionpharma |
08/07/2023 | Derma-Smooth/FS | Fluocinolone Acetonide | Hill Dermac | Novel Labs |
08/07/2023 | Methotrexate Sodium | Methotrexate Sodium | Strides | Daito |
08/07/2023 | Toprol XL | Metoprolol Succinate | Toprol | Granules |
08/07/2023 | Denavir | Penciclovir | Mylan | Torrent |
08/07/2023 | Intuniv | Guanfacine HCl | Takeda | Alembic |
08/07/2023 | Hemabate | Carboprost Tromethamine | Pfizer | Gland Pharma |
08/08/2023 | Children's Motrin | Ibuprofen | Johnson & Johnson | Taro Pharms |
08/09/2023 | Kombiglyze XR | Metformin HCl / Saxagliptin HCl | AstraZeneca | Dr Reddys Labs |
08/09/2023 | Lotemax | Loteprednol Etabonate | Bausch and Lomb | Sun |
08/09/2023 | Paraflex | Chlorzoxazone | Ortho McNeil | Graviti Pharms |
08/10/2023 | Lioresal | Baclofen | Amneal | Acic Pharms |
08/11/2023 | Diovan HCT | Valsartan / Hydrochlorothiazide | Novartis | Amneal |
08/11/2023 | Doryx MPC | Doxycycline Hyclate | Mayne Pharma | Lupin |
08/11/2023 | Lexette | Halobetasol Propionate | Mayne Pharma | Padagis |
08/14/2023 | Firazyr | Icatibant Acetate | Takeda | Eugia Pharma |
08/14/2023 | Aloxi | Palonosetron HCl | Helsinn Healthcare | Nanjing King-Friend |
08/14/2023 | Cozaar | Losartan Potassium | Organon | MSN Labs |
08/14/2023 | Potassium Chloride for Injection Concentrate | Potassium Chloride | Hospira | Nexus Pharms |
08/14/2023 | Lithium Citrate Syrup | Lithium Citrate | Hikma | Rubicon |
08/15/2023 | Bromday | Bromfenac Sodium | Bausch and Lomb | Lupin |
08/15/2023 | Toprol XL | Metoprolol Succinate | AstraZeneca | Lupin |
08/15/2023 | Trokendi XR | Topiramate | Supernus Pharms | Ajanta |
08/15/2023 | Thiola EC | Tiopronin | Mission Pharmacal | Amneal |
08/15/2023 | Aventyl | Nortriptyline HCl | Ranbaxy | Rubicon |
08/16/2023 | Silenor | Doxepin HCl | Currax | Zydus |
08/16/2023 | Zonalon | Doxepin HCl | Mylan | Amneal |
08/16/2023 | Balcoltra | Levonorgestrel / Ethinyl Estradiol / Ferrous Fumarate | Avion Pharms | Xiromed |
08/17/2023 | Selzentry | Maraviroc | ViiV Healthcare | I 3 Pharms |
08/17/2023 | Pepcid | Famotidine | Salix | Annora |
08/17/2023 | Hydroxyzine HCl | Hydroxyzine HCl | Pliva | Graviti Pharms |
08/18/2023 | Ultane | Sevoflurane | AbbVie | Shandong |
08/18/2023 | D.H.E. 45 | Dihydroergotamine Mesylate | Bausch Health | Gland Pharma |
08/18/2023 | Prolixin | Fluphenazine HCl | Bristol-Myers Squibb | Aurobindo |
08/21/2023 | Atacand | Candesartan Cilexetil | ANI Pharms | Prinston |
08/21/2023 | Morphine Sulfate | Morphine Sulfate | Hikma | SpecGx |
08/21/2023 | Calcium Gluconate | Calcium Gluconate | Fresenius Kabi | B Braun Medical |
08/21/2023 | Versed | Midazolam HCl | HLR Technology | Micro Labs |
08/21/2023 | Mucinex | Guaifenesin | Reckitt Benckiser | Marksans Pharma |
08/21/2023 | Sinequan | Doxepin HCl | Pfizer | Unique Pharm |
08/21/2023 | Sutent | Sunitinib Malate | CPPI | Novugen |
08/22/2023 | Retin-A Micro | Tretinoin Microsphere | Valeant | Encube |
08/22/2023 | Zinc Sulfate | Zinc Sulfate | America Regent | Zydus |
08/23/2023 | Esbriet | Pirfenidone | Genentech | Lupin |
08/23/2023 | Chantix | Varenicline Tartrate | PF Prism CV | Alkem |
08/23/2023 | Invega | Paliperidone | Janssen | Ascent Pharms |
08/23/2023 | Bacteriostic Sodium Chloride | Sodium Chloride 0.9% | Hospira | Nexus Pharms |
08/23/2023 | Dexamethasone | Dexamethasone | Hikma | Apotex |
08/24/2023 | Divigel | Estradiol | Vertical Pharms | Novitium |
08/24/2023 | Restoril | Temazepam | SpecGx | Alkem Labs |
08/25/2023 | Vyvanse | Lisdexamfetamine Dimesylate | Takeda | Actavis Elizabeth |
08/25/2023 | Vyvanse | Lisdexamfetamine Dimesylate | Takeda | Hikma |
08/25/2023 | Vyvanse | Lisdexamfetamine Dimesylate | Takeda | Amneal |
08/25/2023 | Vyvanse | Lisdexamfetamine Dimesylate | Takeda | Mylan |
08/25/2023 | Vyvanse | Lisdexamfetamine Dimesylate | Takeda | SpecGx |
08/25/2023 | Niaspan | Niacin | AbbVie | Eywa |
08/25/2023 | Vyvanse | Lisdexamfetamine Dimesylate | Takeda | Sun |
08/25/2023 | Vyvanse | Lisdexamfetamine Dimesylate | Takeda | Sun |
08/25/2023 | Vyvanse | Lisdexamfetamine Dimesylate | Takeda | Norwich |
08/25/2023 | Combigan | Brimonidine Tartrate / Timolol Maleate | AbbVie | Alembic |
08/25/2023 | Vyvanse | Lisdexamfetamine Dimesylate | Takeda | Rhodes |
08/25/2023 | Vyvanse | Lisdexamfetamine Dimesylate | Takeda | Teva |
08/25/2023 | Vyvanse | Lisdexamfetamine Dimesylate | Takeda | Lannett |
08/25/2023 | Vyvanse | Lisdexamfetamine Dimesylate | Takeda | Prinston |
08/25/2023 | Vyvanse | Lisdexamfetamine Dimesylate | Takeda | Apotex |
08/25/2023 | Vyvanse | Lisdexamfetamine Dimesylate | Takeda | Ascent Pharms |
08/25/2023 | Vyvanse | Lisdexamfetamine Dimesylate | Takeda | Alkem Labs |
08/25/2023 | Concerta | Methylphenidate HCl | Johnson & Johnson | Sun |
08/25/2023 | Xelganz | Tofacitinib | PF Prism | Sun |
08/25/2023 | Vyvanse | Lisdexamfetamine Dimesylate | Takeda | Ascent Pharms |
08/28/2023 | Esbriet | Pirfenidone | Genentech | Lupin |
08/28/2023 | Effient | Prasugrel HCl | Cosette | Unichem |
08/28/2023 | Ibrance | Palbociclib | Pfizer | Synthon |
08/28/2023 | Noxafil | Posaconazole | Merck Sharp Dohme | I 3 Pharms |
08/29/2023 | Accutane | Isotretinoin | Takeda | Zydus |
08/29/2023 | CellCept | Mycophenolate Mofetil | Roche | Strides |
08/29/2023 | Viagra | Sildenafil Citrate | Viatris | Novitium |
08/29/2023 | Sterile water for Injection | Sterile water for Injection | Hospira | American Regent |
08/30/2023 | Bentyl | Dicyclomine Hydrochloride | Allergan | Prinston |
08/31/2023 | Mydayis | Dextroamphetamine Saccharate / Amphetamine Aspartate Monohydrate / Dextroamphetamine Sulfate / Amphetamine Sulfate | Takeda | Specgx |
08/31/2023 | Entereg | Alvimopan | Cubist | Hikma |
09/08/2023 | Gadavist | Gadobutrol | Bayer | Jiangsu Hengrui |
09/11/2023 | Diamox | Acetazolamide | Teva | Ajanta Pharma |
09/11/2023 | CellCept | Mycophenolate Mofetil | Roche | Airis Pharma |
09/11/2023 | Prolixin | Fluphenazine HCl | Bristol-Myers Squibb | MSN Labs |
09/12/2023 | Lipitor | Atorvastatin Calcium | Upjohn | Hetero Labs |
09/13/2023 | Augmentin | Amoxicillin / Clavulanate Potassium | US Antibiotics | Deva Holding |
09/14/2023 | Prezista | Darunavir | Janssen | Hetero Labs |
09/14/2023 | Ortho Evra | Ethinyl Estradiol / Norelgestromin | Janssen | Zydus |
09/14/2023 | Advil Liqui-Gels | Ibuprofen | Glaxo | Aurobindo |
09/14/2023 | Librax | Chlordiazepoxide HCl / Clidinium Bromide | Bausch Health | Aurobindo |
09/14/2023 | Famotidine | Famotidine | Novitium Pharma | Micro Labs |
09/15/2023 | Augmentin | Amoxicillin / Clavulanate Potassium | US Antibiotics | Deva Holding |
09/15/2023 | Librax | Chlordiazepoxide HCl / Clidinium Bromide | Bausch Health | Alembic |
09/15/2023 | Levophed | Norepinephrine Bitartrate | Hospira | Caplin Steriles |
09/18/2023 | Pepcid | Famotidine | Salix | Ajanta |
09/19/2023 | Cleosin T | Clindamycin Phosphate | Pfizer | Cadila Healthcare |
09/21/2023 | Diflucan | Fluconazole | Pfizer | Hainan Poly |
09/21/2023 | Mestinon | Pyridostigmine Bromide | Bausch Health | MSN Labs |
09/22/2023 | Tegretol -;XR | Carbamazepine | Novartis | Amneal |
09/22/2023 | Vascepa | Icosapent Ethyl | Amarin | Strides |
09/25/2023 | AK-Fluor | Fluorescein Sodium | Long Grove Pharms | Nexus Pharms |
09/25/2023 | Xeljanz | Tofacitinib Citrate | Pfizer | Slayback |
09/25/2023 | Tapazole | Methimazole | King Pharms | Bionpharma |
09/26/2023 | Depakote ER | Divalproex Sodium | AbbVie | Annora Pharma |
09/26/2023 | Velcade | Bortezomib | Takeda | Scinopharm |
09/27/2023 | Ranexa | Ranolazine | Gilead | Novast Labs |
09/27/2023 | Topamax | Topiramate | Janssen | Aurobindo |
09/27/2023 | Mydayis | Dextroamphetamine Saccharate / Amphetamine Aspartate Monohydrate / Dextroamphetamine Sulfate / Amphetamine Sulfate | Takeda | Sun |
09/28/2023 | Uloric | Febuxostat | Takeda | Macleods |
09/28/2023 | Aubagio | Teriflunomide | Sanofi | Sola Pharms |
09/29/2023 | Nexium 24 hour | Esomeprazole Magnesium | AstraZeneca | Marksans Pharma |
09/29/2023 | Hyzaar | Losartan Potassium / Hydrochlorothiazide | Organon | Granules |
09/29/2023 | Vasopressin in Sodium Chloride Injection | Vasopressin in Sodium Chloride Injection | Endo / Par | Baxter Healthcare |
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